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Clinical Trials in France / NCT02386709
Active, not recruiting Not applicable

Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer

NCT02386709 · tracked via the Priya Life Science France tracker
Sponsor
Centre Georges Francois Leclerc
Phase
Not applicable
Started
2015-03-25
Last updated
2024-02-14

Condition(s) studied

FDG PET

Investigational drug(s) / intervention(s)

FDG PET

FDG PET: FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy

Study summary

Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.

The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patient having been informed of the study * patient affiliated to a social health insurance * ≥ 18 years * patient presenting a breast cancer histologically confirmed * indication of neoadjuvant chemotherapy treatment (classification UICC: II or III) * patient agrees with exploitation of his clinical, biological and image data Exclusion Criteria: * distant metastasis * contraindications to chemotherapy * contraindications to surgery * refusal * serious illness not balanced, subjacent infection * pregnancy or breast feeding * diabetes not controlled (glycemia\> 8 mmol/L) * psychiatric disease * patient under supervision, trusteeship or safeguard of justice

Primary outcome measure(s)

  • difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy — early metabolic response mesure by 18F-FDG PET (difference of Δ SUV) at 3 weeks after neoadjuvant chemotherapy to predict pathologic Complete Response (pCR) by exploiting PET data realized before treatment (PET1) and after a cure of chemothrapy (PET2)

Trial sites (1)

FacilityCityRegionStatus
Emilie REDERSTORFF Dijon France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02386709 on ClinicalTrials.gov ↗ ← All trials in France